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J&J Monistat 3 Combination Pack Cream Extension Clears FDA

This article was originally published in The Tan Sheet

Executive Summary

Johnson & Johnson Personal Products will begin shipping a Monistat 3 Combination Pack cream line extension to food, drug and mass outlets in the second quarter, the firm said Feb. 9.

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Monistat Labeling To Carry Vaginal Miconazole/Warfarin Interaction Warning

Johnson & Johnson Personal Products will update the labeling for its miconazole-containing Monistat 3 and Monistat 7 yeast infection treatments within the year to note the possible interaction between vaginal miconazole and the Rx blood-thinning medication warfarin.

Private label miconazole combo packs

Alpharma receives approval April 16 for ANDA 74-926 and Perrigo, April 20 for ANDA 75-926, allowing both to market three-day miconazole vaginal antifungal treatment combination packs. Equivalent to the reference drug J&J's Monistat 3 Combination Pack, each contains three 200 mg miconazole nitrate suppositories and a 9 g tube of 2% miconazole nitrate cream. Waxman/Hatch marketing exclusivity for Monistat 3 ended April 16, opening up competition for the brand's 5.6% dollar share, reported by Chicago-based Information Resources, Inc. to be worth nearly $68 mil. at U.S. food, drug and mass merchandisers for the 52 weeks ended March 28

J&J Monistat 1 joins Vagistat-1 in one-day yeast infection treatment market.

MONISTAT 1 ENTERING ONE-DAY YEAST INFECTION TREATMENT MARKET under a licensing agreement between Johnson & Johnson and Bristol-Myers Squibb, the patent holder of the 6.5% tioconazole formulation. Bristol-Myers' Vagistat-1, which also contains 6.5% tioconazole, has been the sole entrant in the one-day vaginal yeast infection market until now. In stores nationwide starting June 15, Monistat 1 is being distributed by J&J's Personal Products Company.

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